BRANDED DRUG MAKERS RAISE CONCERNS ABOUT BIOLOGICS

MAY 01, 2007

Representatives of the brand name
pharmaceutical industry told Congress
that current pending legislation to
accelerate the marketing of generic
"follow-on"biologics could create a
"significant risk"for public safety "due
to the significant differences between
biologic products from different manufacturers."
A key problem, according to
the Pharmaceutical Research and
Manufacturers of America (PhRMA), is
that "follow-on biologics are not identical
to innovator biologics."

PhRMA said that its members stand
ready to support the establishment of a
regulatory pathway for follow-on biologics,
but only "if patient safety can be
assured and the innovation of future
medicines is not compromised."Although
generic drug manufacturers are
not required to conduct clinical trials to
secure FDA marketing approval for their
regular "small-molecule"generic pharmaceuticals,
such studies should be
required before generic biologics are
approved, PhRMA officials said.

Significantly, however, none of the
pending bills addressing follow-on biologics
would require such testing. "We
believe that unless clinical trials are
conducted to show the safety and
effectiveness of follow-on biologics?
patients would have no assurance that
the product they are taking is safe,"
PhRMA said.

The branded drug group also raised
concerns that the pending legislation
"would allow a follow-on biologic to be
replaced with a similar productbut a
product with a potentially different
makeupat pharmacies, hospitals, and
physician offices. It is troubling to think
that physicians would not know
whether their patients are receiving the
specific biologic treatment they prescribed,
or a similar product that could
have very different effects on the
patient,"PhRMA said.